Internship – Regulatory Affairs/Quality Assurance

Job Description

Detailed Enriched Job Description: Internship – Regulatory Affairs/Quality Assurance

About Werfen:

Werfen is a dynamic, family-owned, and innovative global leader in specialized diagnostics, founded in Barcelona, Spain, in 1966. With a direct presence in 30 countries and distributors in over 100 territories, Werfen focuses on rapidly evolving diagnostic areas, including Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. The company also boasts an Original Equipment Manufacturing (OEM) business line, specializing in the research, development, and manufacturing of customized assays and biomaterials.

Driven by a commitment to customers, innovation, and quality, Werfen strives to provide healthcare professionals with valuable and complete solutions to enhance hospital efficiency and patient care. Headquartered in the US and Europe, Werfen is a substantial enterprise with annual revenues of approximately $2 billion and a global workforce exceeding 7,000 employees.

Overview: Internship Program

This internship program is designed to offer meaningful professional hands-on experience to students demonstrating strong leadership potential and proven academic performance. Werfen recruits interns majoring in Engineering and Life Sciences fields, aligning placements with specific business needs. Ideal candidates will possess a blend of technical and business knowledge, coupled with robust analytical strength and creative problem-solving abilities.

Responsibilities: Position Description

As a Regulatory Affairs/Quality Assurance Intern, you will engage in entry-level work, applying standard techniques and procedures to a sequence of related tasks. Key responsibilities include:

• Actively participating in the day-to-day activities of the team.
• Aiding other departments on projects relevant to the RA/QA department.
• Gaining an in-depth understanding of Werfen’s products and their associated processes, particularly those you are directly involved with.
• Assisting in nearly all aspects of the RA/QA workflow.
• Contributing to regulatory decisions and submissions for adverse events.
• Authoring Medical Device Reports (MDRs) for submission to the FDA and Health Canada.
• Providing assistance with correction and removal files and communications.
• Undertaking other assignments related to RA/QA to support Werfen’s requirements and priorities.

Key Attributes & Desired Skills:

• Confidence in using Microsoft Word and Excel tools.
• Demonstrates enthusiasm, motivation, and initiative.
• Possesses the ability to thrive within an interactive and energetic workplace.
• Capable of reviewing process procedures, change orders, equipment specifications, validation plans, and reports.
• Assists effectively in creating, reviewing, and maintaining department files.
• Proficient in summarizing findings using computer readouts, statistical summaries, graphs, and other relevant methods.

Minimum Knowledge & Experience Required for the Position:

• Currently pursuing a Bachelor of Science (B.S.) degree in Regulatory Affairs, Life Sciences, Engineering, Finance, Business, or Marketing.
• Must have completed a minimum of 2 college semesters.
• Demonstrated ability to multitask effectively.

Compensation:

The hourly compensation for this role ranges from $22/hr to $30/hr. Individual pay will be determined based on factors such as relevant experience and the college grade level completed.

Closing:

If you are passionate about continuous learning and seek a challenging daily environment, we encourage you to submit your resume or CV. Werfen is an Equal Opportunity Employer, committed to fostering a diverse workplace and strictly prohibits unlawful discrimination, harassment, or retaliation based on any protected characteristic defined by applicable law. For disability accommodation in the online application process, please contact NAtalentacquisition@werfen.com.

Learn more about us at www.werfen.com